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Experimental HIV therapy aims to free patients from daily pills

NCT ID NCT06430905

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests two experimental vaccines, HB-502 and HB-501, designed to teach the immune system to recognize and attack HIV. The study includes 30 people with HIV who are already on suppressive antiretroviral therapy. Participants receive injections every 8 weeks for 24 weeks, followed by 24 weeks of monitoring to check safety and immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HB-502 and HB-501 (arenavirus-based vector therapy)
What this could lead to
If successful, this could point toward a way to control HIV without lifelong daily medication, potentially allowing people to stop antiretroviral therapy.
What could go wrong
This is a very early phase 1 trial with only 30 participants, focused on safety. It may not show strong immune responses, and the study has already been terminated, so results may be limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants 18 to 65 years of age. * Confirmed HIV infection as documented by medical records or confirmatory HIV testing at screening. * Must be on stable suppressive antiretroviral treatment (ART) for at least 48 weeks prior to screening. * Must have plasma HIV RNA levels of \<50 copies/mL (or lower limit of quantitation) for at least 48 weeks prior to enrollment. * Must have a cluster of differentiation (CD)4+ cell count \>450 cells/mm3 and CD4+ cell % of ≥15% obtained within 40 days prior to enrollment. * Is in good general health according to the clinical judgment of the site Investigator. Exclusion Criteria: * History of hypersensitivity or other contraindication to any of the components of the study interventions as determined by the Investigator. * HIV-associated malignancy according to the National Cancer Institute (including Kaposi's sarcoma), and any type of lymphoma or virus-associated cancers. * History of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy. * More than stage 2 HIV-related illness based on the Revised Surveillance Case Definition for HIV Infection (CDC 2014). * Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 156 weeks (i.e., 3 years) prior to enrollment. * Known history of hepatitis B virus (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus infection (defined as hepatitis C virus RNA is detected \[qualitative\]). * Current untreated or incompletely treated active TB disease or untreated latent TB infection. * Has any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive study treatment, or interfere with the interpretation of the study results. * Is a previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded). * Received non-HIV experimental vaccine(s) within the last 1 year. * Has congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site Investigator, such as history of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the Investigator within 24 weeks prior to the start of study therapy. * Received blood products or immunoglobulin within 16 weeks prior to enrollment. * Received systemic steroids at a dose of ≥10 mg/day (prednisone equivalent) for \<30 within 14 days or for ≥30 days within 28 days of first dose of study treatment. * Received any vaccine within 4 weeks prior to enrollment. * Initiated antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary). * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or contraindicate participation in this study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator. * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through a minimum of 12 weeks after the last dose of trial treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beth Israel Deaconness Medical Center (BIDMC)

    Boston, Massachusetts, 02215, United States

  • Brigham and Women´s Hospital

    Boston, Massachusetts, 02115, United States

  • Orlando Immunology Center (OIC)

    Orlando, Florida, 32803, United States

  • Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • The Hope Clinic at Emory University

    Decatur, Georgia, 30030, United States

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